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Notice

Agency Information Collection Activities: Proposed Collection; Comment Request

Action

Notice.

Summary

This notice announces the intention of the Agency for HealthcareResearch and Quality (AHRQ) to request that the Office of Management andBudget (OMB) allow information collection related to implementation of thePatient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to 299b-26, in: “Patient Safety Organization Certification for Initial Listing andRelated Forms and a Patient Safety Confidentiality Complaint Form” Inaccordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed informationcollection.

 

Table of Contents Back to Top

Tables Back to Top

DATES: Back to Top

Comments on this notice must be received by March 30, 2009.

ADDRESSES: Back to Top

Written comments should be submitted to: Doris Lefkowitz, ReportsClearance Officer, AHRQ, 540 Gaither Road, Room # 5036, Rockville, MD 20850,or by e-mail at doris.lefkowitz@.ahrq.hhs.gov.

Copies of the proposed collection plans, data collection instruments, andspecific details on the estimated burden can be obtained from AHRQ's ReportsClearance Officer.

FOR FURTHER INFORMATION CONTACT: Back to Top

Doris Lefkowitz, AHRQ, Reports ClearanceOfficer, (301) 427-1477.

SUPPLEMENTARY INFORMATION: Back to Top

“Patient Safety Organization Certification forInitial Listing and Related Forms and a Patient Safety ConfidentialityComplaint Form.”

The Department of Health and Human Services' (HHS) Agency for HealthcareResearch and Quality (AHRQ) has been delegated the authority to implement theprovisions of the Patient Safety and Quality Improvement Act of 2005 (forbrevity referenced here as the Patient Safety Act) that call for submission tothe Secretary of certifications by entities seeking to become listed by theSecretary as Patient Safety Organizations (PSOs). These entities must certifythat they meet or will meet specified statutory criteria and requirements forPSOs as further explained in the final rule to implement the Patient SafetyAct, published in the Federal Register on November 21, 2008: 73 FR 70732.

The HHS Office for Civil Rights (OCR) has been delegated the authority toenforce the provisions of the Patient Safety Act that mandate confidentialityof “patient safety work product.” This term is defined in the statute, at 42U.S.C. 299b-21(7), and further explained in the final rule (published in the Federal Register on November 1, 2008). Individuals may voluntarily submitcomplaints to OCR if they believe that an individual or organization inpossession of patient safety work product unlawfully disclosed it.

Methods of Collection Back to Top

While there are a number of information collection forms described below, theywill be implemented at different times, some near the end of the three yearapproval period for these standard forms. The forms for certifications ofinformation will collect only the minimum amount of information from entitiesnecessary for the Secretary to determine compliance with statutoryrequirements for PSOs, i.e., most of the required certification forms willconsist of short attestations followed by “yes” and “no” checkboxes to bechecked and initialed.

PSO Certification for Initial Listing and PSO Certification for ContinuedListing Forms: The Patient Safety Act, at 42 U.S.C. 299b-24(a), and the finalrule at 45 CFR 3.102 provide that an entity may seek an initial three-yearlisting as a PSO by submitting an initial certification that it has policiesand procedures in place to perform eight patient safety activities (enumeratedin the statute and the final rule), and that it will comply, upon listing, with seven other statutory criteria. The proposed Certification for InitialListing Form also includes additional questions related to other requirementsfor listing related to eligibility and pertinent organizational history.Similarly, the proposed Certification for Continued Listing Form (for eachsuccessive three-year period after the initial listing period) would requirecertifications that the PSO is performing, and will continue to perform, theeight patient safety activities, and is complying with, and will continue tocomply with, the seven statutory criteria. The average annual burden in thefirst three years of 17 hours per year for the collection of informationrequested by the certification form for initial listing is based upon a totalaverage estimate of 33 respondents per year and an estimated time of 30minutes per response. Information collection, i.e., collection of initialcertification forms, will begin as soon as the forms are approved for use. Theaverage annual burden in the first three years of 8 hours per year for thecollection of information requested by the certification form for continuedlisting is based upon a total average estimate of 17 respondents per year andan estimated time of 30 minutes per response. Collection of forms forcontinued listing will not begin until several months before November 2011which is three years after the first PSOs were listed by the Secretary. (See Note after Exhibit 1.)

PSO Two Bona Fide Contracts Requirement Certification

To implement 42 U.S.C. 299b-24(b)(1)(C), the final rule states that, in orderto maintain its PSO listing, a PSO will be required to submit a certification,at least once in every 24-month period after its initial date of listing, indicating that it has contracts with two providers (45 CFR 3.102(d)(1)).The annualized burden of 8 hours for the collection of information requestedby the two bona fide contracts requirement is based upon an estimate of 33respondents per year and an estimated 15 minutes per response. This collectionof information will begin when the first PSO timely notifies the Secretarythat it has entered into two contracts.

PSO Disclosure Statement Form

The Patient Safety statute at 42 U.S.C. 299b-24(b)(1)(E) requires a PSO tofully disclose information to the Secretary if the PSO has additionalfinancial, contractual, or reporting relationships with any provider to whichthe PSO provides services pursuant to the Patient Safety Act under contract,or if the PSO is managed or controlled by, or is not operated independentlyfrom, any of its contracting providers. Disclosure statement Forms will becollected only when a PSO has such relationships with a contracting providerto report. The Secretary is required to review each disclosure statement andmake public findings as to whether a PSO can fairly and accurately carry outits responsibilities. AHRQ assumes that only a small percentage of entitieswill need to file such disclosure forms. However, AHRQ is providing a highestimate of 17 respondents annually and thus presumably overestimatingrespondent burden. In summary, the annual burden of 8 hours for the collectionof information requested by the disclosure form is based upon the highestimate of 17 respondents per year and an estimated 30 minutes per response.This information collection will begin when a PSO first reports having any ofthe specified types of additional relationships with a health care providerwith which it has a contract to carry out patient safety activities.

PSO Information Form

Annual completion of a PSO Information Form will be voluntary and will provideinformation to HHS on the type of healthcare settings that PSOs are workingwith to carry out patient safety activities. This form is designed to collecta minimum amount of data in order to gather aggregate statistics on the reachof the Patient Safety Act with respect to types of institutions participatingand their general location in the United States. This information will beincluded in AHRQ's annual quality report, as required under Section 923(c) ofthe Patient Safety Act (42 U.S.C. 299b-23(c)). No PSO-specific data will bereleased without PSO consent. The overall annual burden estimate of 17 hoursfor the collection of information requested by the PSO Information Form isbased upon an estimate of 33 respondents per year and an estimated 30 minutesper response. This information collection will begin one year after the firstPSOs are listed by the Secretary.

OCR Complaint Form

The complaint form will collect from individuals only the minimum amount of information necessary for OCR to process and assess incoming complaints. The overall annual burden estimate of 17 hours for the collection of information requested by the underlying form is based upon an estimate of 50 respondents per year and an estimated 20 minutes per response. OCR's information collection using this form will not begin until after there is at least one PSO receiving and generating patient safety work product, and there is an allegation of a violation of the statutory protection of patient safety work product.

All Administrative Forms

The overall maximum anticipated annual burden estimate is 75 hours for all the above described collections of information. Because the forms filled out by PSOs vary over each of their first three years, the table below includes three-year total estimates divided by three to arrive at an annual estimate of burden hours. (See below.)

Exhibit 1—Estimated Annualized Burden Hours Back to Top
Form Number of respondents Number of responses per respondent Hours per response Total burden hours
Note. * The Certification for Continued Listing Form will be completed by any interested PSO at least 75 days before the end of its then-current three-year listing period. Therefore, we anticipate that only those PSOs that have completed the Certification for Initial Listing Form in the first year that these forms are available will complete the Certification for Continued Listing Form during the three-year approval period for these forms. In the out-years, we expect the number of PSOs to remain stable, with the number of new entrants offset by the number of entities that will relinquish their status or be revoked
** The Two Bona Fide Contracts Requirement Form will be completed by each PSO within the 24-month period after initial listing by the Secretary.
*** 1AThe Information Form will collect data by calendar year, beginning in 2010, at a time when it is anticipated that PSOs will have submitted appreciable data to the Network of Patient Safety Databases.
**** A total of 100 PSOs are expected to apply over three years: 50 in year one; 25 in year two; and 25 in year three. Disclosure Statement, Two Bona Fide Contracts Requirement, and even voluntary Information Forms may be submitted by individual PSOs in different years. OCR is anticipating considerable variation in the number of complaints per year. Hence we have expressed the total for each year as the average of the expected total over the three year collection period.
Certification for Initial Listing Form 100/3 1 30/60 17
Certification for Continued Listing Form * 50/3 1 30/60 8
Two Bona Fide Contracts Requirement Form ** 100/3 1 15/60 8
Disclosure Statement Form 50/3 1 30/60 8
Information Form *** 100/3 1 30/60 17
Patient Safety Confidentiality Complaint Form 150/3 1 20/60 17
Total **** 500/3 na na 75
Exhibit 2—Estimated Annualized Cost Burden Back to Top
Form Number of respondents Total burden hours Average hourly wage rate Total cost burden
* Based upon the mean of the hourly wages for healthcare practitioner and technical occupation, National Compensation Survey: Occupational wages in the United States 2007, U.S. Department of Labor, Bureau of Labor Statistics.
Certification for Initial Listing Form 100/3 17 $31.26 $531.42
Certification for Continued Listing Form 50/3 8 31.26 250.08
Two Bona Fide Contracts Requirement Form 100/3 8 31.26 250.08
Disclosure Statement Form 50/3 8 31.26 250.08
Information Form 100/3 17 31.26 531.42
Patient Safety Confidentiality Complaint Form 150/3 17 31.26 531.42
Total 500/3 75 na $2,344.50

Estimated Annual Costs to the Federal Government Back to Top

a. AHRQ

By statute, AHRQ must collect and review certifications from an entity thatseeks listing or continued listing as a PSO under the Patient Safety Act.Additional information collection is also required for entities to remainlisted as a PSO (i.e., submissions regarding compliance with the two bona fidecontracts requirement and reports of certain relationships between a PSO andeach of its contracting providers). The cost to AHRQ of processing theinformation collected with the above-described forms is minimal: An estimatedequivalent of approximately 0.05 FTE or $7,500 per year and virtually no newoverhead costs.

Description Amount
Personnel Support Staff $7,500
Consultant (sub-contractor) services 0
Equipment 0
Supplies 0
All other expenses 0
Average Annual Cost 7,500

b. OCR

OCR cannot conduct its work without collecting information through itsproposed complaint forms. Even if OCR did not use complaint forms and onlytook information orally, it would still have to capture the same informationin order to begin processing a complaint. Therefore, the incremental cost toOCR of processing the information collected from the complaint form is minimaland is equivalent to approximately 0.05 FTE or $7,500 per year with virtuallyno new overhead costs.

Description Amount
Personnel Support Staff $7,500
Consultant (sub-contractor) services 0
Equipment 0
Supplies 0
All other expenses 0
Average Annual Cost 7,500

Request for Comments Back to Top

In accordance with the above-cited Paperwork Reduction Act legislation, comments on the above-described AHRQ and OCR information collection toimplement the Patient Safety Act are requested with regard to any of thefollowing: (a) Whether the proposed collection of information is necessary forthe proper performance of AHRQ's health care research, quality improvement andinformation dissemination functions, including whether the information willhave practical utility; (b) the accuracy of AHRQ's estimate of burden(including hours and costs) of the proposed collection(s) of information; (c)ways to enhance the quality, utility, and clarity of the information to becollected; and (d) ways to minimize the burden of the collection ofinformation upon the respondents, including the use of automated collectiontechniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and includedin the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.

Dated: January 11, 2009.

Carolyn M. Clancy,

Director, AHRQ.

[FR Doc. E9-1009 Filed 1-26-09; 8:45 am]

BILLING CODE 4160-90-M

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